Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study) (NCT03407079) | Clinical Trial Compass
RecruitingPhase 2
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
United States150 participantsStarted 2018-04-05
Plain-language summary
Background:
Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes.
Objective:
To see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized.
Eligibility:
People ages 18-60 who:
* Are black or Hispanic
* Weigh more than 110 pounds
* Have a body mass index of 25-40
* Do not have a condition that requires drug treatment
Design:
Participants will be screened with:
* Medical history
* Physical exam
* Blood, heart, and urine tests
Participants must not eat or drink anything with artificial sweeteners throughout the study.
Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study.
Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes:
* An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours.
* A piece of fat tissue may be taken from the abdomen (biopsy).
* Participants will have a sweet drink. Blood samples will be taken over 2 hours.
Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries.
Overnight Visit 2 repeats Visit 1 except the biopsy.
Then participants will take the capsules for another 2 weeks.
Overnight Visit 3 repeats Visit 1.
Participants may be contacted by phone within 4 weeks after they finish.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. Age: between 18 and 60 years
✓. Female adults who self-identify as Hispanic and/or Black
✓. Body weight greater than 50 kg (110 lb)
✓. Body mass index between 25 kg/m\^2 and 40 kg/m\^2
✓. Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent
✓. Healthy with no known active medical condition or illness that requires drug treatment
✓. Able and willing to consume approximately 4 mg/kg sucralose daily or placebo in form of capsules for
Exclusion criteria
✕. Current use of prescription or non-prescription medication(s), herbal medications and oral contraceptives are also excluded. Certain exceptions are permitted, including vitamins. Other medications may be permitted at the discretion of the investigators.
✕. Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on OGTT)
What they're measuring
1
To explore the effects of sucralose (approx 4 mg/kg x 28 days) on pharmacokinetics of digoxin and midazolam, which are representative examples of P-gp and CYP3A dependent medications.
Timeframe: 28 days
Trial details
NCT IDNCT03407079
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)